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The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.

The INFINITY Angioplasty Balloon Catheter is a intravascular angioplasty balloon catheter with a retractable sheath allowing a variable length inflatable balloon; up to 250mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with radiopaque marker bands denoting 0mm, 100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a 6Fr catheter system with a shaft working length of 150cm. The device uses a semi-compliant balloon with a rated burst pressure of 15atm and an indicated clinical use range of 4atm - 12atm. The balloon expands to a nominal diameter of 5.0 to 5.5mm.

This document, K192399, is a 510(k) premarket notification for the Infinity Angioplasty Balloon Catheter. It establishes substantial equivalence to a predicate device (Boston Scientific Corporation Sterling Over-the-Wire PTA Balloon Catheter, K141112) through a comparison of technological characteristics and performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical study report might. Instead, it lists the types of functional and performance bench testing performed and an overall conclusion of equivalence to the predicate device. The "Acceptance Criteria" are implied to be the successful demonstration that the device's performance is comparable to or better than the predicate, or that any differences do not raise new questions of safety or effectiveness.

Below is a reconstructed table based on the "Functional Testing" section, inferring the acceptance criteria from the nature of the tests and the overall conclusion:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each functional and performance test. It states "representative samples of the device underwent performance bench testing and pre-clinical animal testing."

• Test Set Sample Size: Not specified.
• Data Provenance: The testing appears to be primarily laboratory-based bench testing and pre-clinical animal testing. The location of these tests or the origin of the animal subjects is not specified. It is inherently prospective data as it was generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve clinical studies with human patients or expert interpretation of medical images/data where "ground truth" would be established by multiple experts. The "ground truth" for this device's performance is established through engineering specifications, direct measurements, and a comparison to the established performance of the predicate device.

Therefore, questions about the number of experts used for ground truth or their qualifications are not applicable in the context of this 510(k) submission and the types of studies performed (bench and preclinical animal testing).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study involving human interpretation or subjective assessment that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images. This 510(k) submission is for an angioplasty balloon catheter, a physical medical device, and its evaluation relies on bench, animal, and biocompatibility testing, not diagnostic image interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (angioplasty balloon catheter), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth for this device's performance is primarily based on:

• Engineering Specifications and Design Requirements: The device must meet predefined physical and functional parameters.
• Predicate Device Performance: The device's performance is evaluated against the well-established safety and effectiveness profile of the predicate device.
• Standardized Test Methods: Adherence to recognized international standards (ISO 11135, ISO 10993-1, ISO 10555) provides a validated basis for assessing performance.
• Direct Measurement and Observation: Bench testing involves direct measurement of parameters (e.g., balloon diameter, pressure, inflation/deflation time) and observation of physical characteristics (e.g., kinking, tracking).
• Pre-clinical Animal Outcomes: Animal testing provides in-vivo data on the device's interaction with biological systems, serving as part of the ground truth for safety (e.g., non-toxic, non-irritating) and functionality.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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